In historic step, FDA & DOJ seek injunctions on 2 key unproven stem cell clinic firms

The DOJ and FDA are seeking permanent injunctions in federal court against two of the most widespread and influential of the for-profit, unproven stem cell clinic firms in the U.S. This story is breaking so I’ll have more later this week. The take home is that I see this action as a positive, probably historic turning point for dealing with the for-profit stem cell clinic problem in the U.S. Update: US Stem Cell says it intends to fight the DOJ in court.

Kristin Comella
Kristin Comella, a leader of US Stem Cell

According to the Washington Times:

“One compliant (sic) was filed against U.S. Stem Cell Clinic of Sunrise, Florida, and its officers Kristin Comella and Theodore Gradel. A separate complaint was filed against Stem Cell Treatment Center of Rancho Mirage and Beverly Hills California, and its owners, Elliot Lander and Mark Berman.”

What are these businesses?

Shoot, where do I start?

I just did a post earlier today on how US Stem Cell leadership was talking in a Facebook video publicly about what seemed to potentially be a dangerous GM stem cell-based cancer vaccine. I’m still not sure if this “vaccine” exists and whether it was used in patients or was it was just an idea.

I’ve also posted extensively on US Stem Cell over the years. This blog The Niche may have issued one of the first potential red flags on this biz almost exactly three years ago in May 2015 related to its former incarnation called Bioheart getting into the direct-to-consumer stem cell biz as US Stem Cell/US Stem Cell Clinic.

In addition, I’ve written exhaustively on California Stem Cell Treatment Center and the larger group it is a key part of called Cell Surgical Network.

Elliot Lander and Mark Berman of Cell Surgical Network
Elliot Lander and Mark Berman of Cell Surgical Network

The FDA has now itself issued a statement as well on the new legal action, entitled, FDA seeks permanent injunctions against two stem cell clinics.”

Here’s just part of the lengthy statement from the FDA:

“A permanent injunction is being sought against US Stem Cell Clinic LLC of Sunrise, Florida, its Chief Scientific Officer Kristin Comella and its co-owner and managing officer Theodore Gradel for marketing to patients stem cell products without FDA approval and while violating current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk. The FDA is taking this action because US Stem Cell Clinic did not address the violations outlined in a warning letter to the clinic and failed to come into compliance with the law. The FDA is seeking an order of permanent injunction requiring US Stem Cell and the individual defendants to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements.

The FDA is also seeking a permanent injunction to stop California Stem Cell Treatment Center Inc., with locations in Rancho Mirage and Beverly Hills, California; Cell Surgical Network Corporation of Rancho Mirage, California; and Elliot B. Lander, M.D. and Mark Berman, M.D., from marketing to patients stem cell products without FDA approval. Berman and Lander control the operations of approximately 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center. The FDA is seeking an order of permanent injunction requiring California Stem Cell Treatment Center Inc. and Cell Surgical Network Corporation and the individual defendants to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements.”

The inclusion of Cell Surgical Network is key here in the second action as it is a vast network of clinics that to my knowledge lack needed FDA approvals. How will this step affect the sea of Cell Surgical Network affiliated member clinics? We’ll see, but it probably could cause some to stop operations using non-FDA approved stem cells.

As I said earlier there’s a lot to digest in this breaking story and I’ll post more in the next few days, but I hope this will be a huge victory for patients who want safe, effective, as well as scientifically and medically proven stem cell treatments in coming years.

A big question is how the firms will respond and whether this could evolve into a legal battle. My guess is that the FDA/DOJ will prevail in court. I’m going to reach out to the clinic parties involved for their takes on this big federal step if they are willing to comment. Stay tuned.

9 thoughts on “In historic step, FDA & DOJ seek injunctions on 2 key unproven stem cell clinic firms”

  1. George and Judy,

    I can see both sides of your shared opinions here.
    While the “smack” of conspiracy theories abound, it is interesting to note that some of what used to be considered “conspiracy,” has become accepted as the truth. Cases like the now, medical marijuana and CBD oils industry. Who would think of putting a patent on a weed that grows naturally ( let alone making it illegal) while giving preference to opioid drugs?
    There is a story online that states that both Rockefeller and Carnegie had mutual interests in creating what we now refer to as the pharmaceutical industry and that in that creation they hired a man named “Flexner” to go around and discredit all other forms of healing so as to ensure the success of their drugs as the only “ Approved” form of healing. Whether that story has merit or does not have merit, either way, it is interesting to note that the FDA is the “Approved “ Administration that regulates both what is considered 351 FDA Approved Drugs and what is considered 361 Human Cellular Tissue Products.
    It seems that there are also 351 Approved Drugs that are called “ biologics,” such as Humira, Enbrel and more whose contents appear to read very similarly to the contents of what comprises a HCTP Product, according to the FDA:

    “What is a biological product?
    Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources – human, animal, or microorganism – and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.

    How do biological products differ from conventional drugs?

    In contrast to most drugs that are chemically synthesized and their structure is known, most biologics are complex mixtures that are not easily identified or characterized. Biological products, including those manufactured by biotechnology, tend to be heat sensitive and susceptible to microbial contamination. Therefore, it is necessary to use aseptic principles from initial manufacturing steps, which is also in contrast to most conventional drugs.”

    Sound like something straight out of a science fiction book.

    Although Humira is classified as a Drug, it states on it’s page that a living cell was used to make the product, but that when a person receives the product, it does not contain anything living. ( like HCTPs)The comparison is to a steak and that both the steak and the Drug, must be refrigerated to prevent microbial infection, which is what seems to have gone wrong with a HCTPs that were recently recalled by the FDA ( Liveyon) as it’s maker ( Genetech) was also sent a warning letter about it’s lack of proper laboratory compliance. In addition, the former Advisor for the company said ( publically) that the product was NOT appropriate for therapeutic use in humans, but both the maker and the distributor sold it anyway. People were made sick, including my father-in-law.

    To answer your question, Judy, yes, my 77 year old father-in-law received 2 slow push IV’s of the product called Liveyon, after being told by both a MD and DC that he was getting actual living stem cells. Shortly after receiving the 2nd IV, he developed a severe infection that left him hospitalized with a gut rupture that required an emergency surgery, a toe amputation and a pacemaker. We almost lost him 3 times and then he had a stroke.
    My husband and myself were also told that this live birth tissue product contained living stem cells. We each received blind trigger point injections that we were told would regrow damaged nerves, heal annular tears, repair vertebrae and more. They mixed our blood platelets with the HCTP Liveyon that they were selling like a drug ( by claiming it contained living stem cells) and injected. We both felt like our bodies were trying to “ fight off” something and had to double our laser treatments to deal with additional pain, swelling and stiffness. The product also contained sulfur, to which I have allergic reactions and I told the DC, but he said that it would not matter. It does matter and we do not know the long term affects of these unproven HCTPs.

    It seems a lot of deliberate confusion has been created by the fact that the 361 FDA Registered HCTP companies are referring to themselves as “stem cell therapy” when they do not contain any living stem cells at all according to their 361 FDA Registered HCTP designation. These HCTP companies are injecting ( literally) themselves into the same sales arena as bone marrow aspirate and adipose tissue that is drawn directly from a patient and injected back into them. Plus, from our own documented experience, ( see the DCs and MDs are telling people that the product contains actual living stem cells in order to sell it and they are citing stem cell facts such as when a baby is developing and forming and then switching the conversation to their product and claiming that it will “ magically morph” into whatever the body needs.

    I agree that people should have the ability to make an informed choice based on reliable sources of information in their treatment and that clearly distinct designations should be made as to how these options are “sourced,” meaning from a patient’s own body and back in ( bone marrow aspirate & adipose) vs those “materials” sourced from other humans and animals, along with published clinical research so that it isn’t something out of a Frankenstein lab or an Abrassax harvest as in the movie Jupiter Ascending, if that is possible so that people are not sold a load of balls.

    Is the injunction on the adipose sector a “ Flexner” move or does more research in the proper application of adipose need to be applied, since some patients did go blind with it’s obviously mistaken applications with those people? Is the whole 361 Registered HCTP Product a “ Flexner” created to discredit opposing therapeutic healing modalities and their often “alternative” practioner status or could it be the tool to weed out the unscrupulous who will use unproven therapies on unsuspecting patients for a profit?

    Though the FDA has it’s questionable issues, as Paul stated in one of his posts, “ at least it provides some sort of vetting through clinical trials and testing.” Anyone who has ever found themselves in need of emergency medical treatment who is still alive can attest to the value of that understanding in our modern world.

    That said, as a former broker, the “Food and Drug, “ under one “Administration,” seems like a crafty take on the idea of “ insider trading.”

  2. I’m sorry that your family did not get the promised results. The information I read and listened to from Kristen Comella did not offer promised results, but rather hope. May I ask, was your family physically harmed by the therapy they received?

  3. How do we know some of the treatment options being offered are not big pharma, including the 361 HCTP Registered products ( thrown in with the same Registration as tissue banks) vs 351 Approved Drugs? How can these 361HCTP Registered companies even call their products “ stem cell therapy” when they do not contain any living stem cells as stated by their Registered Vs Approved designation? No rocket science required to understand that these 361 Registered companies are lining their pockets without any regulation as to HOW they are being sold or what is really in them, plus, our family got zero promised results and we also learned that these allograft HCTP 361 Registered companies can contain human birth tissue as well as equine and bovine and since there is no end to birth tissue from mammals, there would seem endless profits. This doesn’t seem like a new game, just more Slytherin strategy.

    1. Agree generally that there is a danger of misrepresentation or downright profiteering here but to call out big pharma just because it´s big pharma is a little below the belt and smacks of conspiracy theory. Unless you can provide evidence of course?

  4. I agree with Brad. I should be allowed to choose my own treatment. The only choices from the FDA are pharmaceuticals riddled with side effects that result in the need for more pharmaceuticals with still more side effects, requiring more pharmaceuticals curing no one of anything and also resulting in an opioid crisis and all too often resulting in an untimely death. But hey, they’re FDA approved. So tell me again how the FDA is looking out for the public? You don’t have to be a rocket scientist to understand that the FDA’s motive is to protect Big Pharma while lining their own pockets.

  5. Hi Brad,
    My family comprises 3 actual patients that received purported, “ stem-cell therapies” and you may read our about our experience at
    Of course, it is good to remember that offense is never given, only taken. While what we were told by an MD & a DC- that what we purchasing were “living stem cells” freely donated by a healthy mother/ child live birth ( and rigorously tested with clinical trials) that would be more effective than what would come from our own plasma (PRP) or bone marrow aspirate due to our age, It seems like PRP and bone marrow aspirate are FDA Approved and have yielded some success. Obviously, there are those who intend to capitalize on creating the confusion between the two.

  6. Where’s the voice of the patients? Where is the ability for people to receive their OWN bodies’ healing resources, unhampered by authorities (so-called) who IN ACTUAL FACT represent an industry, rather than a shared public interest:

    There is a HUGE difference between regulating the claims made about a product or service and PROHIBITING HUMAN BEINGS’ ACCESS to a service or product. You, friends, are simply on the UNETHICAL, INCORRECT side of that line.

    Do you care to comment? Or am I just another ignorant layperson who doesn’t deserve access to my OWN bodies’ healing agents?

  7. @admin – Yes, I wrote this and thanks for moving it to a more appropriate post.

  8. From Bill Jones:
    I guess I might have to eat my “paper tiger” words… However, Lander and Berman are bringing in millions each month, so it’s in their economic interest to drag out this process as long as they can – even if they lose. Let’s say they profit $2500 per treatment. $2500 x 100 clinics x 10 treatments per clinic per month = 2.5 million per month. That’s plenty of cash to fund a lawsuit with anyone and keep on truckin’. In the meantime, clinics, and now labs, are proliferating at an ever-increasing rate. More and more new labs are opening that sell “umbilical cord stem cells” to just about anyone who wants to buy them. They have aggressive salespeople targeting clinics and doctors across the country. At least a couple of them are specifically recruiting chiropractors nationwide to administer IV umbilical cord blood and tissue products to adults and children alike. Lander, Berman and Comella are just the tip of the iceberg at this point. Perhaps the FDA is catching up. Maybe it’s falling further behind. Time will tell. One thing for sure is that the number of patients treated in the US will keep increasing for the foreseeable future. It’s going to be a battle to the death and both sides have the resources to fight it for as long as it takes.

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